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Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Jul 1, 2026 → Feb 1, 2027
See other at-risk trials from University Hospitals Cleveland Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jul 1, 2026 to Feb 1, 2027
    • Eligibility criteria expanded, about 5 words
  2. Re-verified, no change to tracked fieldsv10
  3. Primary and study completion dates: Jul 1, 2025 to Jul 1, 2026v9
  4. Lead sponsor: Marc Pelletier to University Hospitals Cleveland Medical Center
    • Enrollment target: 12 to 20
    • Primary and study completion dates: Feb 1, 2025 to Jul 1, 2025
    • Study title shortened, about 2 words
    v8
  5. Primary and study completion dates: Jul 1, 2024 to Feb 1, 2025v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary and study completion dates: Nov 30, 2023 to Jul 1, 2024v6
  2. Primary and study completion dates: Aug 31, 2023 to Nov 30, 2023v5
  3. Primary and study completion dates: Mar 31, 2023 to Aug 31, 2023v4
  4. Primary and study completion dates: Dec 31, 2022 to Mar 31, 2023v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 19, 2022 to Sep 20, 2022
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this research study is to compare two methods of recovering blood from surgical sponges used during heart and lung surgeries. The two methods are: 1) manually wringing sponges by hand, and 2) automated wringing sponges by an FDA approved suction device. Both methods are already in use in heart and lung surgeries at University Hospitals at the discretion of the surgeon.
Trial Details
NCT Number NCT05545930
Lead Sponsor University Hospitals Cleveland Medical Center
Collaborators: ProCell Surgical Inc.
Conditions
(from sponsor)		 Blood Recovery
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov